Tris(pentane-2,4-dionato-O,O')vanadium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Data source

Reference

Reference Type:

publication

Title:

The acute toxicity and pimary irrintancy of 2,4-Pentadione

Author:

Ballantyne et al.

Year:

1986

Bibliographic source:

drug and chemical toxicology, 9(2), 133-146 (1986)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-2,4-dione

EC Number:

204-634-0

EC Name:

Pentane-2,4-dione

Cas Number:

123-54-6

Molecular formula:

C5H8O2

IUPAC Name:

pentane-2,4-dione

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- weight: 2.0 - 3.0 kg
- environmental temperature: 68-75°C mentioned in publication, assumed to be 68-75°F, corresponding to 20-23.9°C
- relative humidity: 30-65%
- 12hr light-dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 ml undiluted test substance

Duration of treatment / exposure:

4 hour treatment

Observation period:

14 days (inspections after 1 h, 1 d, 2 d, 3 d, 7 d and 14 d)

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: not specified
- Type of wrap if used: application sites were covered with gauze and impervious polyethylene sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test substance was removed gently
- Exposure period: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Remarks on result:

probability of mild irritation

Remarks:

see section "any other information on results incl. tables"

Results 2

Irritation parameter:

erythema score

Basis:

other: animal 1 - 6

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

edema score

Basis:

other: animal 1 - 5

Time point:

other: not specified

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: not specified

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 8

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Erythema:

- very slight local erythema in 5 of 6 rabbits on removal of the occlusive dressing (corresp. to score 1)

- very slight local erythema in 6 of 6 rabbits after 24 h (corresp. to score 1)

Edema:

- slight in 5 of 6 rabbits (corresp. to score 2)

- moderate in 1 of 6 rabbits (corresp. to score 3)

Reversibility:

- after 3 days, half the animals had just detectable erythema, one animal had mild edema

- after 7 days, mild desquamation (no other effects were seen)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Exposure to the test substance acetylacetonate caused very slight local erythema and mild or moderate edema in all 6 animals. Effects were reversible apart from desquamation visible after 7 days. Therefore, this study indicates a mild skin irritating potential of acetylacetonate.

Executive summary:

The primary dermal irritation potential of acetylacetonate was evaluated in this study with New Zealand White rabbits similar to OECD Guideline 404. There was one group of six albino rabbits that received a single, 4 hour, occluded exposure. Each 0.5 mL dose of the acetylacetonate test article was applied to the clipped dorsal skin. At completion of exposure, the bandages were removed and the excess test item removed gently. Application sites were evaluated in accordance with the method of Draize at 1 , 24, 48 and 72 hours, 7 and 14 days after patch removal. Very slight local erythema and mild or moderate edema were noted for all animals. Effects were reversible apart from desquamation visible after 7 days. Therefore, this study indicates a mild skin irritating potential of acetylacetonate. However, the observed erythema and edema scores do not meet the requirements for classification as laid down in Regulation (EC) No 1272/2008.